Status:
NOT_YET_RECRUITING
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Juravinski Cancer Centre Foundation
Conditions:
Vulvar Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The aim of this study is to confirm prospectively if the use of near infrared-indocyanine green (NIR-ICG) alone offers similar accuracy and sensitivity to the gold standard dual technique for sentinel...
Eligibility Criteria
Inclusion
- Adult women (18 years of age) with FIGO Stage IB (\> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and/or imaging and primary unifocal vulvar tumor size of \< 4 cm).
Exclusion
- Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.
Key Trial Info
Start Date :
October 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT06039111
Start Date
October 1 2023
End Date
June 30 2026
Last Update
September 15 2023
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